(289 days)
The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.
The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
This document is a 510(k) premarket notification approval letter for the Oregon Scientific High Precision Body Weight Monitor with Body Fat Index, Model GA101, and an "Indications for Use" statement.
The provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. This is a regulatory approval document and not a scientific study report.
Specifically, the document states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
- The "Indications for Use" are: "The device measures body weight, and impedance using Bioelectrical Impedance Technology (BIA) and calculates body fat percentage, BMI, with results displayed in LCD panel. The intended use of this device is for 7 to 99 years old normal subjects and not for recommended personal with implanted internal device like pacemaker or pregnant women to use this device."
To answer the detailed questions about acceptance criteria and study design, a different kind of document (e.g., a clinical study report, a validation report submitted as part of the 510(k) application, or the 510(k) summary itself)containing performance data would be needed.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's how to address the request based on the lack of specific information in the provided document:
Acceptance Criteria and Device Performance Study (Not Available in Provided Text)
The provided document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device, rather than providing detailed performance data or acceptance criteria from a specific study. Therefore, most of the requested information cannot be extracted directly from this document.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. Performance criteria would typically be defined for accuracy of body weight, impedance, body fat percentage, and BMI calculations. | Not specified in this document. The document states the device "measures body weight, and impedance... and calculates body fat percentage, BMI." However, specific numerical performance results (e.g., accuracy, precision) relative to any acceptance criteria are not provided. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document. Often, data for 510(k) clearance might come from internal company testing, or if clinical data was used, its origin (e.g., country) would be in a study report. The document itself is from the USA FDA.
- Retrospective or Prospective: Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable/Not specified in this document. Ground truth for body composition measurements would typically be established using reference methods (e.g., DEXA for body fat), not expert consensus in this context.
4. Adjudication method for the test set:
- Not applicable/Not specified in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not specified in this document. This device is a standalone body weight and body fat monitor, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "Indications for Use" describes the device's function: "The device measures body weight, and impedance using Bioelectrical Impedance Technology (BIA) and calculates body fat percentage, BMI, with results displayed in LCD panel." This implies standalone algorithmic performance for calculating body fat and BMI from impedance measurements. However, no specific performance metrics like accuracy or precision are provided in this document.
7. The type of ground truth used:
- Not specified in this document. For body composition devices, ground truth for body fat percentage would typically be established using a gold standard method such as Dual-energy X-ray Absorptiometry (DEXA), underwater weighing, or MRI.
8. The sample size for the training set:
- Not specified in this document. (If algorithms are involved, training sets would be used, but this document does not contain details about model development).
9. How the ground truth for the training set was established:
- Not specified in this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN 2 8 2004
Mr. Stephen Li Vice President - Health Care Products IDT Technology Limited Block C, 9/F., Kaiser Estate Phase 1, 41 Man Yue Street Hunghom, Hong Kong, CHINA
Re: K031167
Trade/Device Name: Oregon Scientific High Precision Body Weight Monitor with Body Fat Index, Model GA101 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: December 1, 2003 Received: December 10, 2003
Dear Dr. Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for answer a may 28, 1976, the enactment date of the Medical Device Amendments, or to oonimer of the rest to rial 2011 de noos that have been that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, ato.es or visions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be as made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing for articlequivalence of your device to a legally premarket notification. The FDA inting or saccuman equivalias and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our line following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and and one the regulation entitled, "Mistranding Office of Compliance at (501) 554-1057. This, processor. The Division of Small by reference to premarket notification (21 CF CF Cr In C From the Division of Staall
information on your responsibilities under the Act the first from the (800) 638-2041 information on your responsibilities under Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free decreenc Manufacturers, International and Collsums: 126.0001.10.10.2007/00/01/dsma/dsmamain.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): 5031167
Device Name: Oregon Scientific High Precision Body Weight Monitor with Body Fat Index Model: GA101
Indications for Use:
The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurence of CDRH, Office of Device Evaulation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter Use
David K. Lyonn
(Optional Format 3-10-98)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K031167
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.